Meeting date: / 04 February 2014
Meeting venue: / CEO Meeting Room, Level 3, Hocking Building, Waikato Hospital Campus
Time / Item of business
12.00pm / Welcome
12.05pm / Confirmation of minutes of meeting of 03 December 2013
12.30pm / New applications (see over for details)
3.30pm / i 14/NTB/8
ii 14/NTB/2
iii 14/NTB/3
iv 14/NTB/4
v 14/NTB/7
vi 14/NTB/10
vii 14/NTB/11
viii 14/NTB/12
ix 14/NTB/13
3.35pm / General business:
Noting section of agenda
3.50pm / Meeting ends
Member Name / Member Category / Appointed / Term Expires / Apologies?
Mrs Raewyn Sporle / Lay (the law) / 01/07/2012 / 01/07/2015 / Present
Mrs Maliaga Erick / Lay (consumer/community perspectives) / 01/07/2012 / 01/07/2014 / Present
Mrs Kate O'Connor / Non-lay (other) / 01/07/2012 / 01/07/2015 / Present
Mrs Stephanie Pollard / Non-lay (intervention studies) / 01/07/2012 / 01/07/2015 / Present
Dr Paul Tanser / Non-lay (health/disability service provision) / 01/07/2012 / 01/07/2014 / Present
Ms Kerin Thompson / Non-lay (intervention studies) / 01/07/2012 / 01/07/2015 / Present
Welcome
The Chair opened the meeting at 12.10pm and welcomed Committee members.
The Chair thanked Mary-Anne for coming in for lunch and officially saying goodbye to the Committee. The Committee thanked Mary-Anne for her time and expertise. The chair explained how the NTB Committee, as a whole, works really hard. Mary-Anne has taught the Committee a great deal about communication and accessibility of information, and the Committee is better off for it.
Mary-Anne expressed her thanks and joy from her time sitting on the Committee, noting the quality and passion of the research and researchers that has come through the NTB Committee. The research is often ground breaking and should be recognised as such.
The Chair noted that the meeting was quorate.
The Committee noted and agreed the agenda for the meeting.
Confirmation of previous minutes
The minutes of the meeting of 3 December 2013 were confirmed.
New applications
1 / Ethics ref: / 14/NTB/8Title: / The INTENT trial
Principal Investigator: / Dr Michael Collins
Sponsor:
Clock Start Date: / 23 January 2014
Dr Michael Collins and Kirstin Ryan were present by teleconference for discussion of this application.
Potential conflicts of interest
The Chair asked members to declare any potential conflicts of interest related to this application.
No potential conflicts of interest related to this application were declared by any member.
Summary of ethical issues
The main ethical issues considered by the Committee were as follows.
· Nutrition issues related to kidney transplant are typically obesity and weight gain. Currently the data about best ways to combat post-transplant weight gain is limited. This study aims to generate knowledge with the goal of establish useful information that may guide future research and treatments.
· The Committee commended the readability of the application.
· The Committee queried what the reasons are for weight gain after kidney transplants. Dr Collins explained the reasons for weight gain were to some degree controversial, though factors include dietary restrictions being relaxed post-transplant. Patients often feel better, are no longer having renal failure, and may be on drugs that stimulate appetite.
· Dr Collins confirmed the intervention was fairly basic (motivational interviewing, promoting adherence, food logs and exercise). It was more about being consistent and recording data to see if this approach worked.
· P.2.1.2 (recruitment). Please confirm who is approaching patients and the context of recruitment. Dr Collins explained all recipients post-transplant have a close relationship with the kidney transplant team. Patients spend a week in hospital and are often discharged within a week, with daily visits every week for a month with a staggered reduction in visits over time.
· Dr Collins envisions recruitment to occur by a series of talks over time as participants attend their standard practice appointments following transplant. The participants have a month to be consented from recruitment so they have time to think about it. Dr Collins’s past experience with similar trials found that participants are concerned about weight gain and are quite keen to take part.
· Dr Collins and the Committee both noted there could be a degree of coercion as participants may want to ‘please’ their physician but this is mitigated by the period of time to consider participation and consent.
· Dr Collins confirmed there is no rush to consent before surgery.
· P.3.1 – Please clarify who will screen for eligibility. Dr Collins explained it would be the study team and Co-ordinating Investigator. The inclusion criteria are very broad so most people who undergo a kidney transplant who live in the Auckland region will be eligible.
· F.2.1 – One exclusion criteria is ‘significant risk of non-adherence’. Please explain potential grounds – how is this identified? Dr Collins explained that if the person is ‘totally breaking down’ or unable to continue with the study, perhaps due to the high intensity involvement aspect of the trial. The exclusion criteria was added to ensure they could justify excluding participants who found the intensive attendance was too much. Dr Collins added in past studies there have not been any instances of adherence issues.
· The Committee queried if the standardised body composition measures are validated. Dr Collins explained they had been validated. The standard body composition is considered the gold standard, compared to surrogate measures, including cadaveric body composition comparisons.
· The Committee queried whether the Masters student would be involved in the study long enough to have sufficient data for the Masters project. The Researchers acknowledged the risk for the student, noting there should definitely be enough for the methodology of the study, even if the total amount of anonymous data for analysis is not sufficient.
· The Committee noted the high number of Maori affected by obesity. Is there a particular number considered appropriate for the study Dr Collins explained the transplant numbers are 20-30%. This number fluctuates. This number is lower than the number of Maori who actually have kidney diseases. We will try and recruit as many as we can to the trial, and involvement will be offered to all eligible.
· Dr Collins explained the study has gone through the Maori research committee (Helen Wihongi). Since submission the study has received approval on the condition that the main laboratory can confirm via letter than the samples will be (appropriately managed.
· A.5.1 The Committee noted the study is considered to have no sponsor, noting the DHB is going to be the main locality and would be responsible. Dr Collins responded that he was unsure what to put, noting that it could be the DHB. The researcher added that management would be internal, though has research governance by the research committee at the DHB and would have legal responsibility for the study.
· Committee queried whether all the scientific review had been received, noting peer review for ethics was sufficient (HRC grant) but Australasian Kidney Trials Network review was outstanding. Dr Collins explained that further details have not been received yet, though the reviews are not contingent for study commencement.
· The Committee queried whether any changes from further review came back would be changed and implemented. Dr Collins confirmed that it was unlikely but that any suggested changes would be taken on board.
· The Committee requested the following changes to the Participant Information Sheet and Consent Form:
o Please review the physical activity schedule noting the lack of backslashes.
o The Committee noted on the CF some of the options are not truly optional and should be mandatory for study participation. Dr Collins noted he were aware of this and was happy to take this suggestion on board, as it is a reasonable condition and it makes requirements clear to participants. Dr Collins confirmed they would remove all options from ones where it is a condition of study participation.
o Pg.4: ‘You have the right to access information about you collected for the study’. Please explain how the participant can access this information, such as who they should speak to and the process involved.
o Pg.2: ‘Random selection’. Please explain what this is in lay language for participants.
Decision
This application was approved by consensus with non-standard conditions.
2 / Ethics ref: / 14/NTB/2Title: / Kahungunu Infant Safe Sleep (KISS) Pepi Pod Study
Principal Investigator: / Prof Barry Taylor
Sponsor:
Clock Start Date: / 23 January 2014
Prof Barry Taylor was present by teleconference for discussion of this application.
Potential conflicts of interest
The Chair asked members to declare any potential conflicts of interest related to this application.
No potential conflicts of interest related to this application were declared by any member.
Summary of ethical issues
The main ethical issues considered by the Committee were as follows.
· The Committee noted the study area was very important and it was a clear application.
· Please explain the prior studies involving wahakura. The same intrusive recording was involved in that study? Prof Taylor confirmed that it did involve the same method of observing and this new study is an extension of that study. The reason we did not follow up earlier was because we ran out of funding. Now that we can fund it we can continue with the follow up.
· Has the earlier study started recruitment? Prof Taylor confirmed the study had finished and papers were being written and or published.
· Prof Taylor explained that all the investigators were all Maori and in this community everyone knows everyone. The relationships are strong and family like. Prof Taylor noted that 92% of recruited participants to wahakura study were retained over 6 months which is something we are proud of and shows our relationship in the community.
· The Committee asked if there were any instances in wahakura study of participants being uncomfortable with the recording. Prof Taylor explained they can turn it off at any time. No audio is recorded, just video. Prof Taylor explained that majority of refusals to participate in recordings was from the male partners but these refusals only resulted in 30% of those approached declining.
· The Committee queried the exclusion criteria relating to excluding infants born at less than 36 weeks when this is a known risk factor for SUDI. Prof Taylor explained that the criteria are the same as the prior study in order to compare the data between the studies.
· The Committee queried if only mothers who are breastfeeding are recruited. Prof Taylor explained that many aspects of breastfeeding were important and other feeding patterns were included in the study. The recording covers all other feeding and mothers can be recruited regardless of feeding preference. The committee suggested that the observance of all feeding was made explicit in PISCF as this currently refers only to breastfeeding. .
· The Committee queried the timing of recruitment. Please clarify the difference between being given the information and consenting to participate. Prof Taylor explained they were using DHB processes to conduct recruitment. We are hoping that the consenting visit is when they consent. The Committee asked whether there is any coercion to get a Pepipod as they cost 100+ dollars. Prof Taylor acknowledged the possibility and said they would avoid this.
· The Committee queried if Otago University was the sponsor. Prof Taylor responded they are happy to have Otago University as the sponsor though was unsure at the time of filling out the application.
· The Committee requested the following changes to the Participant Information Sheet and Consent Form:
o The Committee requested that other forms of feeding were added into the PIS/CF.
o Please refer to NTB Health and Disability Ethics Committee.
o Please add more contacts for Health and Disability Advocacy
o The Committee queried whether it was possible to have an independent person to talk to about cultural issues with the study, noting it was difficult due to the close-knit relationship in the community. The Committee felt the health and disability advocate was independent and would suffice.
o Please include information about how vital signs are monitored during the night, in lay language. Prof Taylor clarified that they were recorded, not monitored. Please amend PISCF to state these are recorded rather than monitored.
o The Committee noted on the CF some of the options are not options and should be mandatory, without yes/no options. Prof Taylor explained that some are options. The Committee responded it is just the conditions that are mandatory for study involvement where optional boxes should be removed. The optional ones can stay optional. Please review and remove options and make mandatory statements where applicable..
o Add information on intention of video being used for educational purposes.
o The Committee noted the information will be potentially identifiable, rather than de-identified (b.4.4.1). This is due to the tracking purposes information. Prof Taylor explained that during the study it is potentially identifiable though after the study is over it will be de-identified. The Committee noted for this is just for reference for future applications.
o Please review version dates, ensuring the version date referred to on consent form is provided on information sheet.
o Please clarify why contact information is on the PIS/CF. Prof Taylor said it was for tracking due to the participants frequently moving around. This was accepted by committee.
o Please add the name of the person who is consenting the participant on the CF.
o Please include information about where samples will be stored and analysed
Decision
This application was provisionally approved by consensus, subject to the following information being received.
· Please amend the information sheet and consent form, taking into account the suggestions made by the Committee (Ethical Guidelines for Observation Studies para 6.11).
This following information will be reviewed, and a final decision made on the application, by Mrs Stephanie Pollard and Ms Raewyn Sporle.
3 / Ethics ref: / 14/NTB/3Title: / A study on the Long-term Treatment with BELVIQ (lorcaserin HCl) in obeseand overweight patients with Cardiovascular Disease and/or multipleCardiovascular risk factors
Principal Investigator: / Prof. Harvey White
Sponsor: / Eisai Limited
Clock Start Date: / 23 January 2014
Dr Jocelyn Benatar, a Co-investigator, was present by teleconference for discussion of this application.